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Completed

NCT Number: NCT03595579

Assessing Symptomatic Clinical Episodes in Depression

Randomized, Double-Blind, Active-Controlled Study of AXS-05 for MDD.

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Key information

Conditions

Major Depressive Disorder Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Research Site, Beverly Hills, California, United States

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About this study

This study will evaluate the safety and efficacy of AXS-05 in a randomized, double-blind, active-controlled study in patients diagnosed with major depressive disorder (MDD) experiencing an acute episode.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Currently meets DSM-5 criteria for MDD
  • Body mass index (BMI) between 18 and 40 kg/m^2, inclusive
  • Agree to use adequate method of contraception for the duration of the study
  • Additional criteria may apply

Exclusion criteria

  • Suicide risk
  • History of treatment resistance in current depressive episode
  • History of electroconvulsive therapy, vagus nerve stimulation, transcranial magnetic stimulation or any experimental central nervous system treatment during the current episode or in the past 6 months
  • Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
  • Additional criteria may apply

Treatment and study plan

AXS-05

Drug

AXS-05 taken twice daily for 6 weeks.

bupropion

Drug

Bupropion taken twice daily for 6 weeks.

Primary outcomes

  1. MADRS Score - Overall Change From Baseline

    Time frame: Assessed at week 1, 2, 3, 4, 5 and 6 (averaged over the entire 6-week treatment period)

    The primary objective of the study was to assess the effect of AXS-05 versus bupropion as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) for change in severity of depressive symptoms. The MADRS is a 10-item scale and items are scored between 0-6 points. For each item, a score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity. A maximum total score is 60 points.

Other outcomes

  1. MADRS Score - Change From Baseline to Week 6

    Time frame: 6 weeks

    The primary objective of the study was to assess the effect of AXS-05 versus bupropion as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS) for change in severity of depressive symptoms. The MADRS is a 10-item scale and items are scored between 0-6 points. For each item, a score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity. A maximum total score is 60 points.

Sponsors and collaborators

Lead sponsor

Axsome Therapeutics, Inc.

Industry

Registry information

Official study title

A Randomized, Double-Blind, Active-Controlled Trial of AXS-05 Administered Orally to Subjects With Major Depressive Disorder

Acronym: ASCEND

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 23, 2018
Registry last updated
Sep 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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